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 FDA | CDER | Small Business and Industry Assistance
INDUSTRY NEWS
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FDA issues final guidance on assessing COVID-19-related symptoms in clinical trials
Today, FDA issued the final guidance, Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment.
This guidance supersedes the final guidance of the same name initially issued in September 2020.
This guidance provides sponsors and investigators with considerations for approaches on how common COVID-19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products for the prevention or treatment of COVID-19 in outpatient adults and adolescents. This guidance also provides a set of common COVID-19-related symptoms as an example as well as an approach to their measurement for use in clinical trials.
Although the public health emergency has ended, FDA is committed to supporting continued development of products to treat or prevent the COVID-19 virus by providing timely guidance to assist continued efforts in the post-pandemic era.
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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